Gliadel Wafer and Fluorescence-Guided Surgery With 5-ALA Followed by Radiation Therapy And Temozolomide in Treating Patients With Primary Glioblastoma
RATIONALE: Drugs used in chemotherapy, such as Gliadel wafer and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy and temozolomide after surgery and Gliadel wafer may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying the side effects of fluorescence-guided surgery with 5-ALA given together with Gliadel wafer, followed by radiation therapy and temozolomide, in treating patients with primary glioblastoma.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Evaluation of the Tolerability and Feasibility of Combining 5-Amino-Levulinic Acid (5-ALA) With Carmustine Wafers (Gliadel) in the Surgical Management of Primary Glioblastoma (GALA-5 Trial)|
- Safety, tolerability, and feasibility of combination intra-operative 5-ALA and Gliadel wafers prior to adjuvant radiotherapy plus temozolomide [ Time Frame: Date of surgery to end of temozolomide and radiotherapy treatment ] [ Designated as safety issue: Yes ]
- Time to clinical progression [ Time Frame: from the date of surgery to the date of the first MRI scan fitting the criteria for progression, or the date the clinical detrioration or death was first reported ] [ Designated as safety issue: No ]
- Survival at 24 months [ Time Frame: from the date of surgery to 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2011|
|Estimated Primary Completion Date:||February 2016 (Final data collection date for primary outcome measure)|
Experimental: 5-ALA and Gliadel wafers
This is a single arm feasibility study to evaluate the safety and tolerability of combining 2 technologies (5-ALA and Gliadel wafers) in the surgical management of patients with GBM.
5-ALA is used to generate tumour specific fluorescence as an aid to surgical resection of GBM, prior to the insertion of Gliadel wafers
Other Names:Drug: Gliadel wafers
The implantation of Carmustine Wafers (Gliadel) delivers carmustine- (3-bis 2-chloroethyl 1-1-nitrosourea (BCNU)) directly into the surgical cavity created after tumour resection.
- To establish that the combined use of 5-ALA and Gliadel wafers during fluorescence-guided radical brain tumor resection is safe and does not compromise patients with primary glioblastoma from receiving or completing adjuvant standard radiotherapy plus temozolomide.
- To gather preliminary evidence that the combined use of 5-ALA and Gliadel wafers at surgery has the potential to improve clinical outcome, via measurement of time to clinical progression.
- To gather preliminary evidence that this regimen at surgery has the potential to improve clinical outcome via measurement of survival at 24 months.
OUTLINE: This is a multicenter study.
Gliadel wafers are applied to resection cavity immediately after 5-ALA fluorescence-guided radical brain tumor resection. After recovery from surgery (within 6 weeks of surgery when possible ), patients receive adjuvant chemoradiotherapy comprising standard radiotherapy and temozolomide.
Tumor biopsy and blood sample may be collected at time of surgery for retrospective MGMT status analysis.
After surgery, patients are followed up at post-surgical visits, during subsequent therapy at routine clinic visits, and at 12, 18, and 24 months.
Peer reviewed and funded by Cancer Research UK.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01310868
|Cambridge, England, United Kingdom, CB2 2QQ|
|Royal Preston Hospital|
|Preston, Lancashire, United Kingdom|
|Dundee, United Kingdom|
|Southern General Hospital|
|Glasgow, United Kingdom|
|Hull Royal Infirmary|
|Hull, United Kingdom|
|Leeds General Infirmary|
|Leeds, United Kingdom|
|The Walton Centre|
|Liverpool, United Kingdom|
|King's College Hospital|
|London, United Kingdom|
|University College London Hospital/ National Hospital for Neurology and Neurosurgery|
|London, United Kingdom|
|Royal Hallamshire Hospital|
|Sheffield, United Kingdom|
|Principal Investigator:||Colin Watts||Cambridge University Hospitals NHS Foundation Trust|